Manager, Cell and Gene Therapy (GMP Lab)

Thermo Fisher Scientific•Middleton, WI

1d•Onsite

About The Position

The Manager, Cell and Gene Therapy provides management and direction to staff and resources supporting project activities. The role oversees daily laboratory operations to monitor quality and project timelines, contributes to company policies, quality systems, and training programs, and supports customer responsiveness and client satisfaction. The manager plans and monitors project progress and quality using financial and quality management tools, and develops staff to support department goals and business growth. This is a fully onsite position at the GMP Laboratory in Middleton, Wisconsin. The role manages staff and laboratory resources, coordinates work across internal functions, monitors project performance and financial projections, and works with clients on project proposals, timelines, budgets, analytical matters, and compliance. It also supports senior management and maintains adherence to GMP/GLP and other applicable laboratory and client requirements. The work takes place in laboratory and office settings and may involve PPE, strong odors, and exposure to potentially hazardous elements, including infectious agents. The position requires the ability to work upright or standing for typical working hours, communicate with diverse groups, use standard office equipment and technology, and perform under pressure while handling multiple priorities. Applicants must be legally authorized to work in the United States and pass a comprehensive background check, including drug screening. Relocation assistance is provided.

Requirements

Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
Comparable to 5–8 years of relevant experience, or equivalent experience providing the knowledge, skills, and abilities to perform the job.
At least 2 years of management responsibility.
Ability to demonstrate behaviors aligned with Thermo Fisher's 4i Values.
Ability to train and mentor junior staff.
Ability to foster a collaborative work environment within a team and across business areas.
Effective written, oral, and presentation communication skills.
Problem-solving and troubleshooting abilities.
Understanding of basic financial terms and definitions as applied to the business.
Ability to independently develop project proposals and plans.
Project and time management skills.
Ability to identify and implement efficiencies across multiple programs or projects.
Understanding of the bid process and ability to use others' expertise to develop programs for unique client needs.
Ability to work in a dynamic environment.
Ability to communicate, receive, and understand information and ideas with diverse groups in a comprehensible and reasonable manner.
Ability to work upright and stationary and/or standing for typical working hours.
Ability to lift and move objects up to 25 pounds; the listed environmental conditions also state the ability to lift 40 pounds without assistance.
Ability to work in non-traditional work environments and use and learn standard office equipment and technology proficiently.
Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Must be legally authorized to work in the United States and able to pass a comprehensive background check, including drug screening.

Responsibilities

Oversee staff activities, including interviewing, selection, professional development, goal setting, performance management, coaching, and mentoring.
Review and approve requests for paid time off, leave, and overtime, and review timesheet reports for billing accuracy.
Allocate, schedule, and manage laboratory resources for project activities; update project status and revenue projections.
Communicate project performance metrics, quality updates, and staff development opportunities to employees.
Demonstrate process improvements and efficiency gains, and define and monitor quality and productivity metrics.
Coordinate and prioritize project activities with internal functional groups and support functions.
Identify opportunities within the client base and work with business development to pursue them.
Participate in project definition and client negotiations regarding timelines and budgets.
Participate in audits and departmental capability tours.
Provide clients with recommendations on analytical and compliance issues.
Review and approve laboratory investigations, deviations, and QA facility and data audits.
Prepare and implement SOPs and company operational policies.
Ensure adherence to quality systems and recommend quality system improvements.
Maintain accountability for the group's knowledge and application of GMP/GLP and other applicable laboratory or client practices.
Participate in biannual SOP reviews and changes, and own changes needed to comply with SOPs.
Assist senior management with its responsibilities.